Twice a Year HIV Prevention Drug May Soon Be Available

Will Only Work if People Can Access It & Insurers Cover It

Washington DC… Today, in a surprise development, results of another drug trial for the investigative twice a year HIV preventive drug, lenacapavir, were released, paving the way for potential FDA approval in 2025.  In response to these overwhelmingly positive results, Carl Schmid, Executive Director of the HIV+Hepatitis Policy Institute, issued the following statement:

“The goal now must be to ensure that people who have a reason to be on PrEP are able to access this miracle drug. Thanks to the ACA, insurers must cover PrEP without cost-sharing as a preventive service.  Insurers should not be given the choice to cover just daily oral PrEP, particularly given these remarkable results. The Biden-Harris administration should immediately make that clear.  To date, they have yet to do that for the first long-acting PrEP drug that new plans now must cover.”

Earlier this summer, the HIV+Hepatitis Policy Institute led a letter signed by 63 HIV organizations calling on the Biden-Harris administration to issue guidance to insurers requiring them to cover long-acting PrEP without cost-sharing, following the August 2023 USPSTF recommendation. That updated USPSTF grade “A” for PrEP included a PrEP drug taken every two months, Apretude, that was approved by the FDA in December 2021. However, almost three years later, while some states are requiring insurers to cover it without cost-sharing, the federal government has not yet issued guidance to insurers nationwide to do the same. Under the ACA, newly issued plans beginning one year after a USPSTF recommendation must cover the preventive service.  In this instance, new plans issued beginning this month must be covering Apretude without cost-sharing.  However, to date no federal directive has been issued.

According to modeling conducted for the HIV+Hepatitis Policy Institute, about 55 percent of the estimated 1.2 million people eligible for PrEP have private insurance.

Since the updated USPSTF recommendation is not drug-specific and includes both oral and long-acting PrEP, federal government guidance should make clear that any new PrEP drug, such as lenacapavir, if eventually approved, must be covered by insurers without cost-sharing.

Requiring insurance coverage of the drug and associated services are not the only components of a successful national PrEP program that will be necessary to reach all people who have a reason to be on PrEP and help end HIV in the United States. We need to fully leverage Medicaid and Medicare, along with comprehensive community and provider outreach and educational programs, particularly for communities who are currently not fully benefiting from PrEP, such as Black and Latino gay men, and women.  We also need to ensure that people without health coverage, which we estimate to be 20 percent of those eligible for PrEP, have equal access to new and superior long-acting PrEP. 

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The HIV+Hepatitis Policy Institute is a national, non-profit organization whose mission is to promote quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions.